Kornimate/medical-research-clean huggingface dataset:
dose density fu 75 and fu 90 as adjuvant therapy for early breast cancer

Conditions: Breast Cancer

Summary: this is an open -label randomized phase ii study of dose-dense fluorouracil/epirubicin/cyclophosphamide (fec) administered with epirubicin of 75mg/m2 (fec75) and epirubicin 90mg/m2 (fec90) in untreated patients with early breast cancer.

arm a: the fec75 regimen will be given at the following doses: fluorouracil 500mg/m2 by i.v. bolus or infusion. epirubicin 75mg/m2 by 30 minutes i.v infusion and cyclophosphamide 500mg/m2 by i.v bolus or infusion. all three drugs will be administered intravenously on day 1 of each 14-day cycles. arm b: the fec90 regimen will be given at the following doses: fluorouracil 500mg/m2 by i.v. bolus or infusion.epirubicin 90mg/m2 by 30 minutes i.v infusion and cyclophosphamide 500mg/m2 by i.v bolus or infusion. all three drugs will be administered intravenously on day 1 of each 14-day cycles. pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on day 2 of each cycle. six cycles of adjuvant chemotherapy will be administered in both arms (a + b)

Eligibility criteria:
inclusion criteria: * patients with histological diagnosis of invasive breast cancer * patients with early stage i, ii,iii breast cancer amendable for complete surgical resection. * patients with any nodal status * patients with er and pr -negative tumors. in case of axillary involvement:any hormonal receptors status. * perfomance status 0-1 on the ecog scale * patients indicated for adjuvant chemotherapy * no previous chemotherapy or radiotherapy * patients have to be randomized within 8 weeks after surgery. its recommended that patients will start chemotherapy within 1 month after surgical treatment. exclusion criteria: * active infection * pregnancy/breast feeding * serious concomitant systemic disorders incompatible with the study * second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) * use of any other investigational agent within 4 weeks before enrollment into the study * cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy

Keywords: early breast cancer, fluorouracil
novel coronavirus induced severe pneumonia treated by dental pulp mesenchymal stem cells

Conditions: COVID-19

Summary: evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

open, single center, single arm test design. plan to enroll 24 subjects. on the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial. injection dose: 1.0x106 cells /kg. injection method: slowly and quietly drop 50 ml of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 ml of normal saline.

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18, age ≤ 75, gender unlimited; * 2. novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, rr \> 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (pao2) / oxygen inhalation (fio2) is less than 300 mmhg (1mm hg=0.133 kpa). * 3. those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent. exclusion criteria: * 1. patients with autoimmune diseases in the past or screening; * 2. those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis; * 3. known or self-reported hiv or syphilis infected persons; * 4. have participated in stem cell clinical research; * 5. pregnant or lactating women or those who have fertility plans in the past year; * 6. the estimated life cycle is less than 48 hours; * 7. those who participated in other clinical trials within 3 months before screening; * 8. other conditions that the researcher thinks are not suitable for participating in the experiment.
study of recombinant human insulin-like growth factor i in patients with severe insulin resistance

Conditions: Insulin Resistance; Hyperglycemia

Summary: objectives: i. determine the efficacy and toxic effects of recombinant human insulin-like growth factor i (rhigf-i) on carbohydrate tolerance, insulin action, insulin secretion, hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have failed other therapies. ii. determine the dose and time response of rhigf-i on carbohydrate homeostasis and secondary abnormalities in this patient population. iii. determine the effect of rhigf-i on insulin clearance, the regulation of insulin-like growth factor binding protein 1, the regulation of sex hormone binding globulin, and hypothalamic pituitary gonadal axis in this patient population.

protocol outline: this is an open label study. patients receive the first dose of subcutaneous recombinant human insulin-like growth factor i (rhigf-i) on day 7. patients receive rhigf-i twice daily 15-30 minutes before breakfast and dinner, and are hospitalized for the first week of therapy. patients return for an outpatient exam on day 19 of rhigf-i therapy. approximately 30 days into the therapy, patients are readmitted to the clinical center for repeat screening tests. patients then receive maintenance therapy of rhigf-i for up to 6-12 months. a washout period follows the maintenance therapy phase. patients are followed weekly, biweekly, or monthly depending on blood glucose response of patients off rhigf-i therapy. weekly phone contact with study coordinator is mandatory during this time. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * hematologically proven severe insulin resistance with or without diabetes * fasting insulin greater than 40 u/ml * post glucose insulin greater than 300 u/ml (unless overt diabetes mellitus is present) --prior/concurrent therapy-- endocrine therapy: no concurrent oral hypoglycemic agents and/or insulin other: no concurrent birth control pills --patient characteristics-- * not pregnant * negative pregnancy test * effective barrier contraceptive method must be used by fertile patients * good health

Keywords: endocrine disorders insulin resistance rare disease
efficacy of amantadine treatment in covid-19 patients

Conditions: Patients With Moderate or Severe COVID-19

Summary: demonstration of the efficacy of amantadine over placebo in the population of patients with moderate or severe covid-19 in the initial stage of the disease treated in the hospital

use of high-doses of amantadine in hospitalized patients in the early phase of moderate or severe covid-19, compared to placebo, will shorten the duration of the disease and reduce the risk of death and treatment with invasive mechanical ventilation in intensive care units (icu).

Eligibility criteria:
inclusion criteria: 1. age of respondents - 18 years and older. 2. confirmation of sars-cov-2 infection by pcr 3. hospitalized patient with covid-19, defined according to the following criteria (all of the following criteria must be present): 1. radiological (x-ray of klp or tk klp) features of pneumonia, 2. blood saturation (sao2) measured at rest in the absence of oxygen \<95%, 3. it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive). 4. time up to 10 days from the onset of covid-19 symptoms. the onset of covid-19 symptoms is the first day on which the first symptom typical for sars-cov-2 or covid-19 infection (in the opinion of the attending physician at the center) occurred, such as: fever, cough, shortness of breath, changes in taste or smell , muscle pain, chest pain, diarrhea, nausea, vomiting, sore throat, nasal congestion. exclusion criteria: 1. pregnancy or lactation 2. presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular: a) comorbidities: i) clinically significant hepatic or renal insufficiency; ii) epilepsy or seizures (current or history of); iii) psychiatric or somatic diseases (present or in a history of agitation or confusion, delirium syndromes or exogenous psychoses); iv) cardiovascular diseases such as: severe congestive heart failure, cardiomyopathy, myocarditis, grade ii-iv av block, bradycardia, qt prolongation, perceived u waves or family history of congenital long qt syndrome, severe ventricular arrhythmias a history of heart (including torsade de pointes); v) diseases or conditions that significantly reduce the immunity of a patient (e.g. solid organ transplant, bone marrow transplantation (bmt), aids, immune biologics and / or high-dose steroids (\> 20 mg prednisone daily). b) hypersensitivity to any component of the preparation, c) parallel use of drugs that prolong the qt interval, d) hypokalemia or hypomagnesaemia, e) untreated angle-closure glaucoma, f) use of amantadine currently or in the last 3 months prior to study inclusion; g) participation in another clinical program

Keywords: sars-cov-2 covid-19
effects of delayed cord clamp and/or indomethacin on preterm infant brain injury

Conditions: Intraventricular Hemorrhage; Periventricular Leukomalacia; Brain Injury; Renal Injury

Summary: intraventricular hemorrhage (ivh) and periventricular leukomalacia (pvl) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of ivh and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of ivh in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. several small studies and case reports suggest that delayed umbilical cord-clamping (dcc) may also decrease the incidence of ivh in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. the investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) control (no intervention); 2) dcc alone; 3) prophylactic indomethacin alone; 4) combination of dcc/indomethacin, with respect to survival, ivh or pvl incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. with the steady rise in extreme prematurity births and clear links of ivh to long-term disabilities there is a need to improve care for these patients. this multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.

the investigators will compare efficacy and safety of prophylactic indomethacin, dcc, and their combination, in affecting the incidence and severity of ivh/pvl in infants \<30wks gestational age (primary outcome measure of 'fraction of survivors with no severe ivh or pvl' among the 4 groups), and longer term neurocognitive function. other secondary endpoints and investigations include mechanistic effects of prophylactic indomethacin, dcc, and their combination (blood volume/circulatory status, inflammatory stress, progenitor cells) as well as defining relationships between clinical outcomes and mechanistic measurements among treatment groups.

Eligibility criteria:
inclusion criteria: * pregnant women admitted \>24weeks and \<30weeks gestational age, * in-hospital birth (allowing for cord clamp randomization) exclusion criteria: * preterm infant \ 30weeks at birth * maternal risks identified by obstetrician * fetal risks identified by obstetrician * any congenital abnormality of newborn infant * placental abruption/placental previa * delivery less than 2hrs from consenting to study participation

Keywords: infant brain injury renal indomethacin
assesment of the immune response to rsv vaccine in patients with myeloma, lymphoma and hematological leukemia

Conditions: Myeloma; Lymphoma; CLL; Myelodysplastic Syndrome; Leukemia Acute Myeloid - AML

Summary: a prospective study in which hematological oncology patients who were vaccinated against rsv will undergo a blood test to assess their immune response to the vaccine. as part of the study, hematological oncology patients with cll, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the hematology institute at ichilov, will be offered a blood test to evaluate their immune response to the rsv vaccine (serology, neutralizing antibodies, and cellular response). in the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. the serological test will be conducted in the hospital's virology laboratory. the test result and its significance will be communicated to the patient by the treating hematologist in our clinic. in this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of rsv infection and complications related to the vaccine.

participants 250 single-center research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. this estimate is based on a study published in the nejm which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. we estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received. the study will include patients with chronic lymphocytic leukemia (cll), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. we expect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.

Eligibility criteria:
inclusion criteria: * patients aged 60 years and older * patients diagnosed with multiple myeloma(mm) or lymphoma or cll or myelodysplastic syndrome (mds) or acute leukemia exclusion criteria: * patients who have been previously vaccinated against rsv * patients who have experienced a severe reaction to any vaccine in the past
comparison of stent and prothesis bypass in superficial femoral artery

Conditions: Arterial Occlusive Diseases; Vascular Diseases

Summary: different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. traditionally, these patients should be treated with bypass. if the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. the purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. the study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.

this is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. totally 200 patients will be entered into the trial. the study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（rutherford 3-6）. the lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot. trial participants will be randomized to either stent group or artificial blood vessel bypass group. patients will be followed up for 3 years. study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure. this study will be conducted at 3 centers in beijing, china.

Eligibility criteria:
inclusion criteria: * the patients volunteer to join the trial and sign the formal consent. * the patients are ≥45 year-old and ≤80 year-old. * the patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. the presentation is severe intermittent claudication, rest pain, ulcer or gangrene. * the total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm. * the femoral-popliteal artery has never received bypass or endovascular therapy before. * no obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured. * no obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot. * no surgical contraindications;no infection in operation region. * no available saphenous vein. exclusion criteria: * refuse random treatment. * previous operations on the superficial femoral artery. * acute lower extremity arterial thrombosis. * serious major organ failure. * allergic to the contrast agent or has contrast nephropathy. * no clinical compliance or unfit to join the trial.

Keywords: critical limb ischemia peripheral artery occlusive disease femoropopliteal artery bypass stent
comparative effectiveness of treatment strategies for primary open-angle glaucoma

Conditions: Open Angle Glaucoma

Summary: the primary objectives of the study are: 1. to compare the proportion of patients who achieve a successful response to treatment (reduction in intraocular pressure (iop) of \>15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation. 2. to compare the proportion of patients who achieve a successful response to treatment (reduction in iop of \>15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation. the study is a prospective, observational cohort study and will not provide or recommend any treatment. patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. this inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. all decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. enrollment is expected to begin in february 2011 and continue through 12 months of follow-up after enrollment targets have been reached.


Eligibility criteria:
inclusion criteria: * all adult patients with open-angle glaucoma who have a new or change in therapy (decision to proceed to laser or incisional surgery or initiate a new or additional course of medication). * includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation. * patients willing to complete visual function and quality of life questionnaires exclusion criteria: * patients currently treated with four or more glaucoma medications (at time of enrollment). * patients with no light perception, or otherwise not eligible for further treatment * patients who have neovascular glaucoma, patients with uveitis-associated glaucoma, or patients with angle recession glaucoma. * patients with primary angle-closure or secondary angle-closure glaucoma * patients who have had prior incisional surgery for glaucoma
evaluation of liposomal bupivacaine compared to usual care and its effects on pain for cardiac surgery

Conditions: Cardiothoracic Surgery

Summary: evaluation of liposomal bupivacaine compared to usual care and its effect on pain for cardiac surgery

current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative iv acetaminophen, followed by scheduled oral acetaminophen and supplemental iv and po narcotics. this practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen. opioids are the most commonly used medications to control pain early after surgery because of their high potency. however, their undesirable effects and risk of dependence become limitations. the investigators believe liposomal bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. the primary endpoint will be a 20% reduction in opioids use.

Eligibility criteria:
inclusion criteria: * age \>18 years old * all open heart surgeries from september 1, 2019 - september 30, 2020 * able to read, comprehend and sign the informed consent form exclusion criteria: * pregnancy * \< 18 years old and prisoners * not able to sign informed consent, including patients with an (lar) legally authorized representative * patients with chronic pain requiring scheduled narcotic use * stage 4 kidney disease, child pugh score suggestive of liver cirrhosis/ disease * recent mi within 7 days of scheduled cardiac surgery * known allergy to liposomal bupivacaine or derivative of * have or is currently involved in a research study within 30 days of scheduled surgery